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Maidenhead, GB

Regulatory Affairs Graduate, Consumer Northern Europe(Job Number: 000009XM)

Description

Regulatory Affairs Graduate - Northern Europe

Johnson & Johnson Limited
Maidenhead, Berkshire

Take the opportunity to become part of the success story behind one of the world's fastest growing consumer companies. At Johnson & Johnson we have a truly unrivalled brand portfolio with power brands across multiple categories including Johnson's®, Neutrogena®, Clean & Clear®, Listerine®, Calpol®, and Sudafed®. We have achieved consistent growth and our breakthrough plans for the future make this a great place to further your career. Based in the UK, this regional managerial role covers Europe, Africa and the Middle East.

We are looking for a talented Graduate to support Regulatory Activities for National and/or European procedures for a small number of UK and Maltese products across the J&J portfolio

PRINCIPAL RESPONSIBILITIES

- Management of a product or specified products within a therapy area for Cosmetics, OTC and/or Medical Devices
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Development of regulatory strategies, preparation of regulatory applications and support maintenance activities within relevant therapy area

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Support regulatory activities for National and/or European procedures (Decentralised, Mutual Recognition) as appropriate.

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Develop and support regulatory strategies (local and regional) in line with business plan.

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Complete regulatory activities for a defined number of products to ensure all regulatory obligations and business objectives are met.

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Prepares and compiles regulatory submissions (Marketing Authorisations, Reclassifications etc.), responses to Regulatory Agency (RA) questions and other correspondence in accordance with EU regulations and guidelines.

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Sign off of packaging material, leaflets, SmPCs and advertising material to ensure regulatory compliance via Zinc, COCOON, Starfish systems etc.

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Ensure Marketing Authorisations are maintained and renewed.

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Inform the Regulatory Agency/Department of Health (as appropriate) of product discontinuations and licence cancellations.

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Ensures compliance within the department by ensuring

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Global, EAME and local databases are fully maintained.

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Processes, SOPs and working instructions are adhered to.

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Update relevant local and global databases (e.g Documentum, Aris, GLR, Connect etc.) to track current product information.

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Systems and processes

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Supports publishing activities for the department.

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Provide regulatory advice and perform due diligence for product acquisitions and distributor agreements with third parties.

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Database Compliance

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Support update to the global, EAME and local databases e.g. Global Labelling Repository, Aris Register, Symphony and Product List / Renewal / Sunset Clause trackers to ensure compliance in the department.

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Update eMC and In-Demand systems for UK product licences.

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Manage Calls for Information and assist in any Pharmacovigilance related activities within the UK Regulatory Department

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Receive and compile responses to Calls for Information (CFI) through liaison with UK and EAME colleagues.

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Ensure responses are submitted in a timely way in line with standard procedures and metrics set by the VP Regulatory Affairs in European Regulatory.

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Provide responses to ad-hoc requests received from UK PV group or Global Reg Med Mailbox.

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Good Regulatory Practice

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Maintain awareness/knowledge of current regulatory legislation.

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Ensures regulatory best practice at all times.

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Monitor changes in the regulatory environment and highlight any potential impact on McNeil Products Ltd / J&J products.

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Customer Service

- Act as an ambassador for the Regulatory Affairs department and continues to raise profile of team both internally and externally.
- Represent Regulatory Affairs on cross-functional product/project teams and provides regulatory advice (as appropriate).
- Interact with Regulatory Agency
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Seek advice when appropriate.

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Respond to requests for further information and queries.

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Resolve any regulatory matters and expedite approval of pending applications.

- Provide regulatory guidance to internal stakeholders, to allow them make key decisions on business critical activities and project feasibility.
- Represent J&J and provide regulatory advice at e.g. joint Company/Trade Association initiatives, Regulatory Agency meetings etc (as appropriate).

Qualifications


- Life sciences or chemistry graduate to honours level or equivalent.
- Excellent written and verbal communication skills.
- Attention to detail.
- Effective organisational skills.
- Works under guidance to plan, conduct, and manage regulatory submissions and multiple projects to meet department and company objectives.
- Works under supervision to determine and develop approaches to solutions with technical guidance on limited to moderate problems.
- Project management, understanding of regulatory environment, interaction with the Regulatory Authorities, commercial / strategic awareness, implement regulatory strategy, managing and maintaining Marketing Authorisations.

What type of mark will you make? Your unique talents and perspective can make a vital contribution to innovative products that improve the lives of people everywhere. At Johnson & Johnson, our company's ethical character is defined by our people. We strive to attract people with strong, positive values, and we develop, reinforce and reward those values. With a broad range of excellent commercial career development opportunities (within customer, shopper and brand marketing, national accounts etc), with the world's sixth largest consumer company this could be the best career move you'll make.

We respectfully request Government Officials to identify themselves as such on application; for the purpose of the Foreign Corrupt Practices Act. If you decide to apply for the position, any personal data which you provide shall be processed by Johnson & Johnson Medical, a Johnson & Johnson company. Your personal data shall be processed for the purposes of recruitment, recruitment policy and selection.

Primary Location:Europe/Middle East/Africa-United Kingdom-England-Maidenhead
Organization: Johnson & Johnson Limited (8700)

Job: Regulatory Affairs